Senior Validation Lead

7 days ago

Dublin, Dublin City, Ireland beBeeValidation Full time €60,000 - €65,000
Job Title: Senior Validation Engineer

We are seeking a highly skilled and experienced Senior Validation Engineer to join our team. The successful candidate will be responsible for ensuring that the validation activities associated with a Syringe Filling Line for a Sterile fill finish facility are in compliance with GMP and quality requirements.

Main Responsibilities:
  • Develop, execute, review, and approve CQV test documentation (Factor Acceptance Testing (FAT), Installation Verification (IV's), Functional Testing (FT's), Site Acceptance Testing (SAT) and Performance Qualifications (PQ's) associated with a Syringe Filling Line.
  • Prioritize and manage validation protocols.
  • Contribute to site Validation Master Plans and Standard Operating Procedures (SOP's).
  • Analyze and report on relevant validation data/metrics.
  • Assist in exceptions and deviation resolution and root cause analysis.
  • Review validation planning documents detailing overall strategy for the project.
  • Review and Approve Qualification summary reports (QSR).
  • Generate Validation Summary reports.
  • Support the development of User Requirement Specifications (URS's) and Quality Risk Assessment for Equipment and Automated Systems (QRAES).
Requirements:
  • 6+ years experience in Engineering or Validation.
  • Technical qualification at third level or equivalent in Engineering.
  • Extensive knowledge and demonstrated experience executing Validation activities for Pharmaceutical / Biotechnology projects.
  • Experience of sterile / biotech equipment within the pharmaceutical industry is preferred.
  • Demonstrated strong Communication skills.
  • Experience using Paperless Qualification Systems is preferred.
  • Strong understanding of a risk-based approach to commissioning, qualification, and validation within the biotechnology industry.

This is an initial 12-month contract role. Interested candidates should submit an updated CV. Please note that we cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland.

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